Regulators in UK and Spain confirm Almirall/GW's Sativex is approvable

The regulatory authorities in the UK and Spain have reached consensus that all issues related to the approval applications for Sativex, a cannabinoid being developed by the UK's GW Pharmaceuticals and Spain's largest drugmaker, Almirall, have been resolved. The decentralized procedure has therefore been closed with a positive recommendation that Sativex is approvable.

Sativex is the world's first prescription medicine derived from the cannabis plant. The product was approved in Canada in 2005 ' where it is sold under license by Bayer -  and is also available in a number of countries as an unlicensed medicine, which enables doctors to prescribe the product to individual patients who they consider may benefit. However, GW has struggled to gain acceptance for its product in Europe, as well as the USA, where it is licensed to Japan's Otsuka.

The European regulatory procedure will now enter its final phase. Known as the 'national phase,' this takes place separately - in this case - in the UK and Spain and its purpose is to finalize local wording on product packaging and related documents. After this process is completed, national marketing approvals can be granted in each respective country.